BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE FOG INHIBITOR WITH SPONGE NONFB100

    MDR report key: 6641577 · Received June 14, 2017

    Report

    Report Number
    1836161-2017-00054
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    May 16, 2017
    Report Date
    May 16, 2017
    Manufacturer
    ASPEN SURGICAL PRODUCTS, CALEDONIA
    Product Code
    OCT
    PMA / PMN Number
    K932449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED A COMPLAINT IN REGARDS TO ITEM NUMBER NONFB100 WITH THE LOT 123297. THE COMPLAINT WAS FOR ¿FOAM SEALED IN PERIMETER OF PACKAGING¿. THE ISSUE WAS CONFIRMED AS THE RECTANGULAR FOAM PAD HAD BEEN SEALED ON THE SEAL OF THE POUCH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420387 MEDLINE FOG INHIBITOR WITH SPONGE NONFB100 DR FOG OCT ASPEN SURGICAL PRODUCTS, CALEDONIA MD-1001 123297

    Patients

    Seq Age Sex Outcome Treatment
    1